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Mavyret Approved for Chronic Hepatitis C

FDA news release; 2017 Aug 3

Publish date:: August 17, 2017

FDA has approved Mavyret (glecaprevir and pibrentasvir) for the treatment of chronic hepatitis C (HCV) in adults who have genotypes 1-6 disease but are not suffering from cirrhosis.

Indications: Mavyret is intended for patients with HCV who do not have cirrhosis and who are new to treatment. It can also be taken by patients with compensated cirrhosis and those with moderate to severe kidney disease and those who are on dialysis.

Dosage and administration: 3 tablets (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) taken orally once daily with food. Patients without cirrhosis should take the drug for 8 weeks and those with compensated cirrhosis for 12 weeks.

Adverse reactions: The most common adverse reactions in patients taking Mavyret were headache, fatigue and nausea. The drug is contraindicated in patients taking atazanavir and rifampin.

Citation:

US Food and Drug Administration. FDA approves Mavyret for Hepatitis C. FDA Web site. August 3, 2017, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm570038.htm, http://www.rxabbvie.com/pdf/mavyret_pi.pdf. Accessed August 9, 2017.

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